This is a randomized, double-blind, Phase II, placebo-controlled trial adding on to a background of effective treatment designed to evaluate the efficacy, safety, and pharmacokinetics of PRO95780 combined with paclitaxel + carboplatin + bevacizumab therapy in patients with previously untreated Stage IIIB, Stage IV, or recurrent non-small cell lung cancer (NSCLC). Approximately 120 patients will be randomized to one of two treatment arms.

Ability to understand and willingness to sign a written informed consent

Histologically or cytologically confirmed NSCLC

Advanced NSCLC

Measurable disease

ECOG performance status of 0 or 1

Age ≥ 18 years

Use of accepted and effective method of contraception, i.e., double barrier contraceptive methods (e.g., diaphragm plus condom) or abstinence during the course of the study and for 6 months after the last study treatment administration for women, and 1 month for men

Exclusion Criteria:

Squamous cell histology

Prior malignancy other than NSCLC (except in situ basal cell carcinoma or in situ cervical cancer), unless it has been treated with curative intent and there is no evidence of disease for ≥ 3 years prior to randomization

Untreated or unstable CNS metastases

Myocardial infarction or an unstable or uncontrolled disease or condition related to or impacting cardiac function within 1 year prior to randomization

Uncontrolled hypertension

History of arterial thrombosis, stroke, or serious hemorrhagic disorder within 1 year prior to randomization

Major surgical procedure within 28 days prior to randomization

Serious non-healing wound ulcer, or bone fracture within 21 days prior to randomization

Persistent history of gross hemoptysis relating to the patient's NSCLC

Participation in clinical trials or undergoing other investigational procedures within 30 days prior to randomization

Pregnancy (e.g., positive HCG test) or breast feeding

Known sensitivity to any of the products to be administered during the study

Any disorder that compromises the ability of the patient to provide written informed consent and/or to comply with study procedures

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480831